Quality Assessment of Artemether/Lumefantrine Tablets Sampled from Pharmacies in Accra,
Using the MVHimagePCv8.exe Color Software
571
system. Production plants with ineffective quality opera-
tions that do not operate according to Good Manufactur-
ing Practice (GMP) may end up manufacturing products
that would not meet specifications and thus considered
substandard. However it is important to state that a drug
or product may lose its quality after production if trans-
portation, storage and other post production protocols are
not effective or followed effectively.
For a product to pass quality test, analytical results
obtained in laboratory experiment or calculated from
experimental measurements are compared with stated
acceptance criteria in internationally accepted compendia
(e.g. USP). The acceptance criteria are mostly set to
make room for analytical errors, unavoidable variations
in manufacturing and compounding and for deterioration
to an extent considered acceptable under practical condi-
tions [9].
An official standard product shall be formulated with
the intent to provide 100% of the quantity of each active
ingredient stated on the label. Variations are however
possible and do occur no matter how carefully the proc-
essing was done. In view of this, the International Con-
ference of Harmonization (ICH) and the United States
Pharmacopoeia (USP) recommend that assay of a drug
substance or finished product shall range from 80% to
120% of the test concentration [11].
In reference to the above stated criteria, the analysis
employed in this study used the above mentioned range
to determine the acceptability or otherwise of both Arte-
mether and Lumefantrine in the tablet samples analyzed.
Thus any sample that had their percentage concentrations
falling within the range was said to be satisfactory. Sam-
ples that fell below or above the range were said to have
questionable states of quality.
AL-S4 failed artemether content, not because there
was not enough active drug ingredient, but because there
was more than the allowable amount. This could have
happened because of poor quality control measures at the
manufacturing facility, or a deliberate attempt to increase
the content of one ingredient (most likely the cheaper) to
make up for a lower amount of the second ingredient.
The lumefantrine content of AL-S6 is of grave concern.
Although it is difficult to ascertain the cause of the very
low lumefantrine content, drug degradation cannot be
used as a reason for this observation. The sample was
well within the expiry date and it is highly unlikely that
the active ingredient will degrade by almost 50%. It
could be attributed to poor manufacturing practice or a
deliberate attempt to decrease the amount of the Lume-
fantrine content.
Most of the samples analyzed showed a percent error
of 15% or less. Very few, however, showed very high
variability. A further modification of the method, for
example, use of a better solvent for both ingredients
might improve the product yield. The method used here
has been shown in other experiments in our lab (results
not shown here) to be reliable and robust.
6. Conclusions
The results showed a trend that looked like artemether
concentrations are being increased at the expense of
lumefantrine probably due to cost. However, this is an
unacceptable practice because the role of lumefantrine in
its right amount is important in this combination therapy
and cannot be compromised.
In addition to augmenting the effect of highly effective
artemether, lumefantrine also prevents the development
of resistance against the artemisinins, a group of antima-
larials that the world is trying hard to protect against re-
sistance to their use.
Malaria is a deadly disease that affects people of all
ages and it is a major cause of morbidity and mortality in
Ghana. Since its discovery many drugs have been used to
manage the disease with a lot of changes being made
over the years due to the development of resistance.
This problem has been largely attributed to non com-
pliance and the availability and use of substandard or
counterfeit products on the market resulting in treatment
failure and the subsequent development of resistance.
Methods for drug analysis have been confined to well
equip laboratories with expensive and sophisticated equip-
ments thus making it difficult to quickly and easily ana-
lyze and detect possible substandard drugs entering the
market.
With the development of such simple methods of drug
analysis, more drugs can be tested quickly and easily to
help do away with the substandard ones.
The MVHimagePCv8.ex colour technology for drug
analysis was used in this project to analyze Artemether/
Lumefantrine products obtained from Community Phar-
macies in Accra, Ghana. The results after the analysis
revealed that, two out of the 9 samples (AL-S4 and AL-
S6), failed the test. These results therefore show that
there may still be antimalarials on the market that are
substandard and thus need to be investigated and dealt
with.
REFERENCES
[1] A. O. Ajibola, “Essential Medicinal Chemistry,” 3rd Edi-
tion, Hope, Ibadan, 2005, pp. 404-429.
[2] Hazel, et al., “Malaria Case Management in Ghana,
Training Manual for Pharmacist,” 2009, p. 8.
http://en.wikipedia.org/wiki/Malaria#History
[3] WHO, “Report of an Informal Consultation,” Geneva,
13-17 November 2000.
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